Pathogen detection and display system

ABSTRACT

A pathogen detection and display system is configured to discover and display the location of substances of interest, particularly pathogens that can spread infection. The detection and display system can be used in healthcare facilities on surfaces, medical equipment and devices, patients, and staff, for example.

RELATED APPLICATIONS

This patent application claims the benefit of U.S. ProvisionalApplication No. 62/149,912, filed on Apr. 20, 2015, entitled, “PathogenDetection and Display System,” the contents and teachings of which arehereby incorporated by reference in their entirety.

BACKGROUND

Each year in the United States alone, 1.7 million patients contract anosocomial, or hospital-acquired infection (HAI). Ninety-nine thousandpeople die annually as a result of these infections, making this thefourth leading cause of death in the United States. The direct medicalimpact of HAIs on the healthcare system is estimated at $35-$45 billion.It is estimated that the combined direct and indirect costs; i.e. impacton humanity, is $96-$147 billion.

An HAI is an infection acquired in hospital by a patient who wasadmitted for a reason other than that infection. There are numerousvarieties of pathogens that can result in HAIs, some of which areantibiotic resistant. The most commonly reported pathogen (as high as30%) is Clostridium difficile (C. diff.), which is also one of the mostdifficult to remediate. Other pathogens can include Acinetobacter, MRSA,VRE, and Norovirus, for example.

HAIs and their treatment are a complicated problem, and for many yearshave been considered an unavoidable risk and expense. Additionally, thefederal Centers for Medicare Services has deemed that certain infectionsare avoidable, and the care associated with them ineligible forreimbursement. Private payers are following Medicare's lead andbeginning to deny payments for HAIs. This trend will certainly continue.Since the Affordable Care Act was enacted in 2010, there have beenseveral changes to the policies regarding reimbursement of HAI costs.The financial burden associated with HAIs is being shifted to healthcareinstitutions. Beginning in 2015, the 25% of hospitals with the highestrates of HAIs will face penalties of one percent of their Medicarepayments.

An additional burden incurred by hospitals as a result of HAIs is anincreased length of stay (LOS). Reimbursements from payers to hospitalsare treatment-based and independent of the length of stay, so there is aclear benefit to keeping LOS to a minimum. For a patient contracting anHAI, LOS increases from an average of 3.6 days to 22.2 days, with thehospital absorbing the additional costs.

More than ever, the pervasive HAI problem within the healthcare systemaffects the reputations of hospitals and healthcare providers. TheAffordable Care Act of 2010 has established new reporting mechanismsthat create online resources where the public can compare the incidenceof HAIs at their local hospitals. Clinical care outcomes will becomevisible to patients, allowing them to become more selective about theircare providers in ways that will have a significant effect on ahospital's overall patient volume and bottom line.

SUMMARY

Recent academic and clinical research has begun to demonstrate thatinfections can be dramatically reduced through proper disinfection ofthe hospital environment. However, it is hard to clean what cannot beseen. The cleaning, disinfecting and sanitizing of surfaces infacilities that service the public happens continually. Every minute ofeach day wait staff in restaurants wipe down tables with diluted bleachspray, janitors clean public restroom floors with a rolling bucket andmop, and hospital housekeeping staff disinfect patient rooms with aspray bottle and wipe rag then move on to the next room. There are nostandards for cleaning. Since there is no method to visualize pathogens,the cleaning products and methods used are based on tradition and commonknowledge rather than on scientific evidence.

These efforts are carried out with a host of cleaning products to removedirt and debris, and chemical disinfecting and sanitizing products areused to kill bacteria, spores and viruses. Technologies utilizingultra-violet light, dry fog, ozone, hydrogen peroxide gas and othermedia are employed to sanitize hospital rooms. With all this effort,technology, manpower and regulation, the spread of infection frompathogens left on cleaned surfaces is still commonplace, with costly,debilitating and even deadly results for the humans who come intocontact with the surfaces.

An inherent problem with the current methods of monitoring, cleaning anddisinfecting is that pathogens cannot be seen with the naked eye. Thecleaning staff is literally blind in the environment that they arecharged with cleaning. Thorough disinfection of hospital rooms is a keycomponent of preventing infections. Numerous chemicals and methods areavailable that have the ability to kill pathogens. However, infectiouspathogens are microscopic and difficult to detect and identify. Becauseof this, pathogens are often left behind after the cleaning anddisinfecting process, and have the ability to infect a subsequentpatient.

Current methods to monitor and verify cleaning activities are limited.For instance, in some hospitals a method using fluorescent dots and UVlight is used to verify that a surface has been cleaned. The dots areplaced in high-touch locations that are unknown to the cleaning staff.The rooms are then cleaned, and then the locations are checked todetermine whether the dots have been removed. This practice verifiesthat the dye has been removed, but provides no information about thepresence of harmful pathogens.

Photoluminescence is used to test for the presence of adenosinetriphosphate (ATP). Wherever organic biomass is found, ATP will bepresent. This test helps to indicate that a surface has been cleaned,but, as with fluorescent dye, does not detect the presence of harmfulpathogens. While tests such as these are a step in the right direction,it still leaves the staff blind as to what needs to be cleaned and theefficacy of cleaning techniques.

There are methods available that can identify a pathogen. The mostcommon involves taking a sample from a surface and culturing it in agrowth medium. Others include DNA testing, chromatography/spectroscopy,and an emerging technology using disposable biochips. Depending on thetype of test used, definitive results can take up to 48 hours. Without amethodical sampling procedure and a method to display results, these arelimited to use as spot sampling techniques.

Conventional methods attempt to predict trends and even length of stayrelated to HAIs. These methods are generally based on data mining andretrospective analysis, although some also include patient and locationtesting. Results are used to predict trends over time, but none of thesecan, or are intended to, show the current locations of pathogens.

Other conventional systems include cleaning validation systems which areused to help assure that particular cleaning procedures have beenfollowed. These systems often include means to verify that disinfectantshave been used, staff has cleaned their hands, etc. Some prior artmentions the use of pathogen culturing to validate cleaning. Thedisadvantage to relying on validation is that a patient, visitor orstaff member may enter the space and touch a surface immediately aftervalidation, depositing a pathogen onto the surface, and contaminatingthe validated room. This can result in a false confidence of roomcleanliness.

Clearly, hospitals need better strategies for preventing HAIs.Embodiments of the innovation disclosed herein provide hospital staffwith the ability to obtain a picture of the presence and locations ofpathogens within the facility. With this information, pathogens can beremediated and HAIs will be reduced. The prevention of HAIs will becomean evidence-based practice rather than one that depends on traditionalmethods that are scientifically unsupported.

By contrast to conventional cleaning methodologies, embodiments of thepresent innovation relate to a pathogen detection and display system. Inone arrangement, the pathogen detection and display system is configuredto discover and display the location of substances of interest,particularly pathogens, which can spread infection. Pathogens includeorganisms, such as an infectious particle capable of producing adisease, that cause disease or illness to its host or any substance ofinterest that can cause illness, irritation, etc. Embodiments of theinnovation can be used in healthcare facilities on surfaces, medicalequipment and devices, patients, staff, etc. It can also be used inrestaurants, on cruise ships, in theaters, prisons or any other spacewhere the spread of pathogens can cause harm. This disclosure willdescribe a system for use within a health care environment, but it willbe seen that it can be employed in other applications as well.

Hospital staff is challenged with chasing invisible and deadly pathogensthrough the environment without clear feedback about which remediationefforts work and which do not. Despite their best efforts, they have noway to confirm which actions are effective in reducing HAIs. With thisdisconnect, hospitals have adopted a “bundled approach” to intervention.This approach includes written policies and procedures, education ofstaff, selection of cleaners and disinfectants, methods of cleaning, andmonitoring of cleaning practices. Without data, there is merely a loosecoupling of remediation activities and efficacy. Ultimately, there is noclear proof which bundles are truly effective for reducing HAIs.Additionally, there are no standards for cleaning within a healthcarefacility, which means that each facility, unit and even cleaning crewmay use different techniques.

This innovation is an integral part of an evidence-based practice (EBP)that can significantly reduce the occurrence of HAIs. Disclosed is ascientific auditing system as opposed to a verification or validationsystem. The process of continually auditing a facility and displayingthe location of pathogens precludes the need for verification ofcleaning since it creates the opportunity to adapt behaviors andprotocols based on scientific evidence.

EBP is the integration of scientific evidence, clinical expertise andclient/patient perspectives. The current innovation contributes thescientific evidence to the practice. With knowledge of the location ofpathogens within a facility, clinical expertise can be employed todetermine methods and protocols that best remediate and preventpathogens. With the continuing auditing cycle, the efficacy of themethods and protocols will become evident. This continuing scientificevidence will allow clinicians to modify or select the remediation andprevention methods and protocols that are most effective. Decisions willno longer be based on opinion and ungrounded tradition but on visible,demonstrable evidence. This system will provide the health care facilitywith the necessary tools to determine best practices.

In its basic embodiment, this innovation is a three part system:

Collect; healthcare or environmental services staff collect samples fromrooms and locations within those rooms as instructed by the system.

Read; the sample results are read to identify potentially harmfulpathogens and their locations.

Display; the presence and location of pathogens are displayed in amanner that provides a visual representation of their location.

In one embodiment, the system automatically analyzes the collectedsamples, formats the results as needed, then displays individuallytailored information to front line staff, infection control, hospitaladministration, admissions, housekeeping and other departments andindividuals as needed. The display of information can be via tablet,smart phone, computer, wall-mounted video monitor, existing facilitycommunications systems or other convenient means.

In certain embodiments, the system is configured as an adaptive,self-learning system that utilizes the continuing feedback to maximizeits ability to detect pathogens. It can adapt collecting techniques toparticular facilities or types of facilities, location within afacility, and type of room or even specific rooms and location withinrooms. It may take into account the pathogen types and their traits,such as the locations where they are commonly found, for example. Thesubstantially continuous feedback cycle provides this adaptive systemwith the information it needs to determine the most effective samplingprotocols based on factors that can include type of pathogen, locationof pathogen, size of colony and various historical data; then uses thedata to adapt sampling methods and locations based upon quantifiableresults. Some embodiments may use these adaptive learning methods todirect cleaning and remediation efforts by providing specificinstruction based on the type of pathogen found, its location, etc.

In one arrangement, a pathogen detection and display system, comprises acollection device configured to retrieve a sample from a facility, areading device configured to receive the sample from the collectiondevice, to process the sample, and to generate pathogen sampleinformation related to the sample, a control system disposed inelectrical communication with the reading device, and a display devicedisposed in electrical communication with the control system. Thecontrol system is configured to receive, from the reading device,primary pathogen sample information related to a pathogen associatedwith a facility. The control system is configured to correlate theprimary pathogen sample information with a pathogen transmission factor,the pathogen transmission factor associated with transmission of thepathogen within the facility. The control system is configured to, basedupon the correlation of the primary pathogen sample information and thepathogen transmission factor, transmit pathogen action informationassociated with the primary pathogen sample information to the displaydevice.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, features and advantages will beapparent from the following description of particular embodiments of theinnovation, as illustrated in the accompanying drawings in which likereference characters refer to the same parts throughout the differentviews. The drawings are not necessarily to scale, emphasis instead beingplaced upon illustrating the principles of various embodiments of theinnovation.

FIG. 1A illustrates a schematic representation of a detection anddisplay system, according to one arrangement.

FIG. 1B illustrates an example of a detection and display system,according to one arrangement.

FIG. 2 illustrates an embodiment of a pathogen display screen.

FIG. 3 illustrates a historical graph provided by a display.

FIG. 4 shows a drop-down menu that can be used to change the historicaldate range.

FIG. 5 shows a change in the historical date range to display a priorthree months of history.

FIG. 6 illustrates a map of Unit 1 showing room locations and roomnumbers.

FIG. 7 illustrates a detail window.

FIG. 8 shows pathogen detection results from a one month period.

FIG. 9 illustrates unit data provided in graph form.

FIG. 10A illustrates a patient perimeter for a bedridden patient.

FIG. 10B illustrates a patient perimeter for a patient with limitedmobility.

FIG. 11 illustrates an example of a double room in which both patientsare ambulatory

FIG. 12 illustrates a collection system having a collecting device and areplaceable collector, in one arrangement.

FIG. 13A illustrates an exploded view of the collection system of FIG.12.

FIG. 13B illustrates attachment of a collector to a housing of thecollection device.

FIG. 13C illustrates the collector attached to the collection device.

FIG. 14A illustrates a bottom perspective view of the collection deviceof FIG. 12 having the collector disposed in a first position.

FIG. 14B illustrates a bottom perspective view of the collection deviceof FIG. 12 having the collector disposed in a second position.

FIG. 15 illustrates the collection device of FIG. 12 in position readyto sample a horizontal surface.

FIG. 16 illustrates the collection device of FIG. 12 with a retractablehandle disposed in a lowered state.

FIG. 17 is a flowchart that illustrates a decision path for each zone.

FIG. 18 illustrates a schematic representation of the components withina reader system, according to one arrangement.

FIG. 19 illustrates a carousel, according to one arrangement.

FIG. 20 illustrates certification levels of a pathogen auditing program.

DETAILED DESCRIPTION

Embodiments of the present innovation relate to a pathogen detection anddisplay system. In one arrangement, the pathogen detection and displaysystem is configured to discover and display the location of substancesof interest, particularly pathogens that can spread infection.Embodiments of the innovation can be used in healthcare facilities onsurfaces, medical equipment and devices, patients, and staff, forexample. It can also be used in restaurants, on cruise ships, intheaters, prisons or any other space where the spread of pathogens cancause harm.

FIG. 1A illustrates a schematic representation of a detection anddisplay system 10, according to one arrangement. As shown, the systemincludes a collection device 12, a reading device 14, a display device16 and a control system or controller device 18.

The collection device 12 is configured to retrieve samples from afacility or worksite for the testing of pathogens. For example, thecollection device 12 can be a computerized device having a controller13, such as a memory and a processor. One arrangement of the collectiondevice 12 is illustrated and described with respect to FIGS. 12-16below. Returning to FIG. 1A, the collection device 12 is disposed inoperative communication with the reading device 14. For example, thecollection device 12 is configured to provide the collected (e.g.,physical) samples to the reading device 14 for processing.

The reading device or system 14 is configured to receive the collectedsamples and processes the samples to determine whether a pathogen ispresent. For example, with reference to FIG. 1A, the reading device 14can be a computerized device having controller 15 such as a memory and aprocessor. One arrangement of the reading device 14 is illustrated inFIG. 18 below. Returning to FIG. 1A, the collection device 12 isdisposed in electrical communication with the control system 18. Forexample, the reading device 14 is configured to communicate with thecontrol system 18 via a wired or wireless network 19, such as a LAN or aWAN. During operation, the reading device 18 is configured to transmitpathogen information 20, which relates to a detected pathogen, to thecontrol system 14.

The control system 18, such as a computerized device having controller21 such as a memory and a processor, is configured to utilize thepathogen information 20 to provide information, such as pathogen actioninformation 24, regarding the detected pathogen, such as via displaydevice 16, to an end user. An example of the operation of the controlsystem 18 is provided in detail below.

FIG. 1B illustrates an example of the collect-read-display functions ofa pathogen detection and display system 10, such as illustrated in FIG.1A, according to one arrangement. The collection and reading devices 12,14 and display 16 shown here are functional examples only. Theseelements 12, 14, 16 and their functions may take many alternative formsdepending upon the specific applications and technologies used. Examplesof the three functions of the system 10 are provided as follows:

Collection Functionality

In one arrangement, the collection device 12 is configured to takesamples to test for pathogens. These are generally taken from surfaceswithin a hospital, and can include a room's walls, floor, windows, etc.,as well as beds and other furnishings, medical devices and equipment.Samples may be collected from patients, caregivers, visitors or from anyother entity that may provide usable information to the system.Collection technicians may be nursing or environmental staff, or otherpersonnel trained in the process, who may be hospital employees or staffsupplied by an outside company. The collection device 12 provides thestaff members with instructions that include all the informationnecessary for collection. Instructions may include the time when acollection is to be taken, the specific location or locations to sample,the type of sample to take (i.e. there may be different collectiondevices for different pathogens of interest), disposition of collectedsample and any other relevant information.

Reading Functionality

In one arrangement, the reading device 14 accepts the collected samplesand processes them to determine whether a pathogen is present. Thedetermination may be as basic as pathogen or no pathogen, or may includespecific pathogen family, genus, species, colony count, biomass or otherpertinent information. In one arrangement, the pathogen informationdetermined here is provided to the display device 16 via the controlsystem 18. In one embodiment, the reading device 14 is automated andconfigured to have the technician insert the collection device 12 intothe reading device 14. However, a completely manual system is within thescope of this innovation. For example, manual culturing andidentification can be provided by a morphologist, or by DNA or otherhigh-tech methods. Alternately, an automated system, such as describedbelow, can be utilized

Displaying Functionality

In one arrangement, the display device 16 presents pathogen informationdetermined by the collect and read functions to the personnelresponsible for hygiene, infection control and management of thefacility. The display method and format can be tailored to the targetuser to provide them with the most appropriate information in an easy touse fashion. The display output example in FIG. 1B may be well suitedfor use by infection control and cleaning staff. It depicts a floor mapof a hospital outlining individual rooms. The highlighted rooms arecontaminated by pathogens, and the others are not. This display outputprovides hospital staff with a simple visual understanding of the areasthat need immediate attention. A display output meant for a hospitalmanager may present statistics, reports and analyses rather than a map.Display outputs may be tailored by individual, function or othercriteria. The display device 16 may be interactive, allowing the user toselect and choose information and presentation format, as preferred.Additionally, the display output may be provided on any suitable displaydevice 16, such as computers, smart phones, tablets, wall-mountedmonitors, dedicated devices, existing facility communication systems,etc.

In one arrangement, the system 10 includes a control system. In oneembodiment, the system 10 is configured as a cloud-based system, such ashaving a server device, which can support one or multiple facilities.For example, using a secure internet connection, cellular or othersuitable communication technology, results from the reader device 14 aretransmitted to the control system 18 having a controller 21, such as amemory and a processor, configured to process the results and totransmit the processed results to one or more display devices 16.Alternatively, the control system 18 can utilize a facility's mainframecomputer, a device with an embedded system, a PC-based computer or othersuitable technology. In one embodiment, the system 18 informs hospitalstaff of the location of pathogens. In one arrangement, it is theresponsibility of the staff to determine the proper course of action toremedy the situation. This system 18 provides the scientific evidence,such as typically required for an evidence-based practice. The staffsclinical expertise is used to remediate the problems and to understandthe ramifications of their choices based on ongoing pathogen auditingresults. This provides the staff with the ability to see the location ofpathogens and to realize the efficacy of their protocols. Thecomparative effectiveness of protocols will become apparent over time.This will provide the opportunity to maximize remediation efficacy andminimize contamination, resulting in fewer HAIs.

Knowledge of the location of pathogens will also give hospital staff theability to adapt patient treatment. For example, if a particularpathogen is found in a patient's room and the patient is deemedsusceptible to it, a course of antibiotics may be started prior to thepatient showing symptoms of infection. Other behavioral changes canresult from this innovation as well, because for the first time,hospital staff will be able to truly understand the effectiveness andresults of their methods, procedures and techniques.

In use, the control system 18 is configured to provide instructions forcollecting samples. For example, the control system 18 is configured toprovide a trained technician or team of technicians with instructionsvia smart phone, tablet, existing hospital communication system, orother convenient device. This may be the same display device 16 that isused to display the pathogen location results, or it may be a differentdevice. These instructions may also be delivered by a non-electronicdevice, such as a paper printout. These instructions include informationsuch as which rooms are to be sampled, the sampling location or multiplelocations within that room, the type of sample to be collected if morethan one is available, time of day to take the samples, disposition ofthe sample after it is collected, or any other information that ispertinent to the collection and handling of samples.

The technician then proceeds to collect samples as instructed. In onearrangement, the sample is collected using a collection device 12 thatallows relatively rapid collection by touching a collection device 12 toa surface within the room, equipment and devices within the room, oreven patients and staff. This collection device 12 may be used to take asingle sample, or may be used to sample multiple locations; i.e. bedrail, window sill, etc., as instructed. Each individual collectiondevice 12 is identified and logged into the system. Each collectiondevice 12 can be individually serialized and can be read into the systemby use of bar code, RFID tag or any other convenient identificationmethod. Identification may also be made by manually logging a serialnumber or other identifier into the system. Alternative methods may alsobe used. For example, individual labels may be printed, whereby thestaff member taking the collection places the label onto the collectiondevice 12 at time of collection. This label correlates each collectiondevice 12 with its sampling instruction. Numerous methods can be used bythe system 10 to link any sample to its instruction, as well as time ofday, etc. In this manner, the pathogen display system 10 can relate eachcollected sample to its correct location and time.

Once samples are collected by the collection device 12, the samples areprovided to the reading device 14. In one embodiment, the reading deviceis configured to automatically detect the presence of a pathogen basedupon the samples. For example, once the collection device 12 is insertedinto the reading device 14, the reading device 14 is configured toautomatically determine whether a pathogen is present or not. This maybe accomplished by a variety of mechanisms, from manual culturing andidentification by a morphologist to DNA or other high-tech methods, tothe automated system described later. Delivery of the collected samplesto the reader may be accomplished in a variety of ways, such as humancurrier, existing pneumatic delivery systems, robotic delivery devices,etc. The reading device 14 may be localized to a hospital floor or acentralized hospital location, or even a more centralized, regionallocation outside of the hospital that may serve multiple facilities.

The collect-read-display process can function as well with variousreading device models. In one arrangement, if an automatic readingdevice 14 is not used, a manual system may be employed. For example, asample may be collected using a currently available swab sampler that isidentified as previously described. The sample is then delivered to alaboratory, where it is cultured and grown. A morphologist determineswhether a sample contains a pathogen. This information can then bemanually entered into the system.

As indicated above, the collection device 12 and reading device 14 areconfigured as separate devices. Such indication is by way of exampleonly. In one arrangement, the collection and reading devices can becombined into a singular device that consolidates the collect and readfunction. This singular device would collect and read a sample and sendthe pathogen information to the control system. A singular devicecontaining collect, read and display functions would also be anticipatedby this innovation.

Display

Once the pathogen information is collected and read, the control system18 provides information, such as pathogen action information 24, to thedisplay device 16. In one embodiment, the pathogen action information 24is configured as a facility map 30 outputted by the display device 16.The facility map 30 is configured to provide a pathogen sampleidentifier, such as a type of pathogen identified in the facility, apathogen sample location, such as a visual representation of thelocation of pathogens within the facility, and a pathogen sample time.Also as part of the pathogen action information 24, the display device16 can provide a list of room numbers with an indication of a positiveor negative test result, or may provide detailed information about thetype of pathogen found, specific location of detected pathogens (bedrail, door knob, blood pressure monitor, etc.), and any otherinformation that may aid in remediation and prevention.

The display example in FIG. 1B depicts a display output that may be usedby front-line staff responsible for remediation and patient safety. Inthis example, a map of the floor plan depicts room locations andidentification. Rooms where no pathogens have been found are shown in afirst color, such as blue. Rooms that have pathogen contamination areshown in a second color, such as red. This provides the staff with aninstant visual recognition of locations that need attention. Otherinformation presented in the FIG. 1B example is the name of the hospitaland floor within the hospital, total number of contaminated rooms, andan activity log containing the status of recent audits.

In some embodiments, the display device 16 is configured as aninteractive device that can be accessed through a touch screen or otherselection method. For example, a staff member may select a room ofinterest by touching the screen to get detailed information about thetesting and results within that room. The example in FIG. 1B depicts aroom selected with additional information shown. Through the interactivedisplay, the user may select a variety of informational and visualformats. Examples include multiple levels of detail, historicalinformation, data trends, graphical representations vs. lists, or anyother data and presentation that can be helpful to the staff. Followingare illustrative examples of the display, its contents andinteractivity.

FIG. 2 shows an embodiment of a pathogen display home screen or displayoutput, as provided by display device 16. In it can be seen a plan viewof the four units within the hospital 200. Units 1 and 2 are depicted ina first color, such as red, indicating that pathogens have been found inthese units. The intensity of the color indicates the relative number ofpositive pathogen results within that unit. For example, unit 2 is adarker shade than unit 1, meaning more pathogens were found there thanin unit 1. Within the unit maps are the total number of positivepathogen results 201, in this case 5 rooms are contaminated. Alsodisplayed is the change in the number of contaminated rooms 202, in thiscase it has increased 2.2% from the previous reporting period. Thereporting period may be the current calendar day, the prior 24 hours, orother period as desired. Units 3 and 4 are shown as unshaded (i.e., inwhite) meaning that they are not included in the testing. If a unitbeing tested has no pathogen presence, it can be depicted in a secondcolor, such as green, blue or another color, indicating it ispathogen-free.

Also provided by the display output are the facility name 203 and thepathogen being detected 204. The display output may show the totalnumber of room that have tested positive along with the percentagechange for the facility 205, and may display the average patient stay206, in this case 3.2 days. The display output may also show the maptitle and information date 207 as well as current date and time 208. Anavigation panel 209 allows the user to select the page view for thehome screen as well as individual units. The current view is the mapview of the home page 210. The display output may include features forease of navigation. For example, selecting a unit on the screen maybring up the detailed display for that unit. Selecting the chart view211 brings up an historical graph display of pathogen results.

The display output can also provide standard statistical calculationssuch as average, mean, standard dev, or % change, for example. FIG. 3shows a display output of a historical graph 300. The date range 301shows that this graph represents the time period of Feb. 19 to Mar. 19,2015. The graph 300 depicts the total number of rooms that test positivefor each day of the month. As can be seen in this example, during theone hour and seven minute elapsed time between the current date and time208 of FIG. 2 and current date and time 302 of FIG. 3, the total numberof contaminated rooms during the reporting period has risen from 7 to 9303. This illustrates how the display device 16 functions in real time.

FIG. 4 shows a drop-down menu 401 that can be used to change thehistorical date range. For example, a user can select the drop-down menu40 to change the display from a prior month of history to a prior threemonth of history. FIG. 5 shows the range changed to display the priorthree months of history. Selecting any point 501 on the graph maydisplay information specific to that date. A trend line 502 may be usedas an indicator of the level at which action must be taken, in thiscase, four contaminated rooms. The probability of spreading infection isrelated to the amount of pathogen present and the number of locationsthat are contaminated. There may be a number of contaminated locationsunder which only a limited remediation effort is necessary for theprobability to remain low. Anything above this line may requireimmediate and/or intensive effort to reduce the pathogen content. Thisnumber may be decided upon based on historical data and trends, as wellas location or other factors. For example, an oncology unit may requirea lower contamination tolerance than an outpatient unit since theoncology patients will tend to have compromised immune systems, makingthem more susceptible to infection. Along with this trend line, thegraph may show the average, median, standard deviations or other desiredinformation.

FIG. 6 depicts an example display output as a map 600 of Unit 1, showingroom locations and room numbers. This is a map 600 of the currentreporting period, in this case, 24 hours. As illustrated, any room shownin a first color 601 has tested positive for pathogens in its mostrecent audit. Rooms shown in a second color 602 did not test positivefor pathogens in their most recent audit. Rooms that are half shaded 603are rooms that have a pending test result. The color of the shaded halfindicates the prior day's test result. In this figure, room 117 has beenselected, which has brought up a window 604 showing the prior week'sresults, with each day shaded in a first or second color depending onresults.

To the right of the map is provided a status window 605 having statusentries 607. Status entries 607 provided above the line 606 arecompleted tests, while entries provided below the line 606 are pending.The completed test results are displayed in a first or second color toindicate positive or clear (negative) results, and show the room number,result status and time of test. The pending results show the roomnumber, status and the time remaining until results are known. Thestatus in this case is Reader, meaning that samples have been collectedand are in the reader awaiting results. Other status entries may includetests that are scheduled, collections being made, in transit betweencollection and reader, etc. The status line may be selected and draggedupward or downward to view past or future status entries.

User selection of a status entry 607 may bring up a detail window 700 asthe display output, as shown in FIG. 7. The window 700 can includedetailed information about an individual test result including roomnumber, date of collection, staff member making the collection, thepatient in the room, test results, notes, and may even include dataabout staff on duty or any other relevant information includingqualitative and/or quantitative pathogen data.

As with the graph results shown previously, the display dates 702 may beselected by an end user to view historical data. FIG. 8 shows thedisplay output providing results 800 from a one month period. Any roomsthat tested positive within this time are shown in a first color, alongwith the number of days that the test results were positive. This can bedisplayed as the number of positive results, can be shown as apercentage, or may be a calculated number indicating a persistencefactor. A persistence factor may make it possible to recognize roomsthat should be investigated because of a persistence or pattern ofpersistence of pathogens. The persistence factor may be a calculationbased on number of recurrences, size of pathogen colonies and otherelements that will be determined by practice of the art. Selecting aspecific room can bring up a window with that room's historical data.Additionally, the display may be cycled through day by day to view thechanging results. As with the whole facility map, the unit data may beviewed in graph form 900 as in FIG. 9.

Although not shown in the Figures, one aspect of the system 10 is theability to display not only the location and number of occurrences ofpathogens, but also quantitative information as well. This may bepresented as the percentage of surfaces that are contaminated withpathogens. This may be the percentage of surfaces tested, or anextrapolation of the total contaminated surfaces within an area based ontest sample locations and results, and the understanding of pathogengrowth and contamination trends learned from historical data.Alternatively, or in addition, the quantitative measure may relate tothe size of the pathogen colonies. The size may be the area of anindividual colony, expressed in units such as square inches, squarecentimeters, etc. It may be the volume in cubic inches, cubiccentimeter, etc., or it may be the mass of the colony in grams, ounces,etc. The display may present this information in a manner that is mosthelpful in understanding contamination levels, trends, etc. For example,the charts and graphs shown in the figures that display informationabout room contamination may include this quantitative information asrough data, percentage of increase or decrease, levels requiringimmediate attention, etc.

In one arrangement, the data and presentation can be user dependent. Forexample, an infection control officer may view a hospital-widecontamination map. A historical map can identify locations of recurringpathogens, indicating problem areas that need investigation. A hospitaladministrator can obtain analytical information, comparisons, andreports. An admissions department may use the information to placeincoming patients with a known susceptibility into rooms withhistorically low pathogen content. As can be seen, the system allows allusers of the system to visualize the information in a manner that servesthem best, from a whole-hospital “heat map” to details of a singularcollection. Additionally, alerts and updates may be delivered using amessaging system, and may include visual and auditory communications.These are only a few examples of its display capabilities.

Some embodiments may include a two-way communication capability betweenthe user and the system 10. In this manner, a user can request specificinformation regarding collection, results, statistics, etc. They mayalso prompt the system 10 to perform additional assays or otherfunctions if they perceive a need.

The display device 16 can be configured as any appropriate technology orcombination of technologies. These may include smart phones, tablets,personal computers, wall-mounted monitors. These devices can be wirelessor wired. As new display technologies become available, they can beintegrated into the system 10.

Control System

Returning to FIG. 1A, the control system 18 is configured to manage theflow of information, in both directions, between the collection device12, reader device 14, and display device 16. An example of the operationof the control system 18 is provided in detail below.

For example, the control system 18 is configured to receive pathogensample information 20 from the reading device 14 where the pathogensample information is related to a pathogen associated with a facility.For example, the pathogen sample information 20 provided by the readingdevice 14 can identify a pathogen sample type (i.e. a type of pathogenidentified by the reader), a pathogen sample collection time, and apathogen sample collection location of a given facility.

After receiving the pathogen information 20, the control system 18 isconfigured to correlate the pathogen sample information 20 with apathogen transmission factor 22, such as stored in a database, thepathogen transmission factor 22 associated with transmission of thepathogen within the facility. In one arrangement, the pathogentransmission factor 22 can identify a variety of ways in which apathogen can spread through a facility. The pathogen transmission factor22 can identify patient demographics, hospital staff information, orcleaning protocols used, with respect to particular pathogens found inthe facility.

For example, assume the pathogen information 20 identifies a particularpathogen as occurring in a given room of a facility, such as a hospital.In response to receiving the pathogen information 20, the control system18 is configured to correlate the pathogen information 20 with a varietyof pathogen transmission factors 22 (i.e., factors that affect how apathogen is spread in the facility), such as a listing of the hospitalnurses that have been in the room, identification of the movement of thepatient relative to that room, and/or identification of the movement ofhospital equipment relative to that room. In this case, assume thepathogen sample information 20 identifies the pathogen as C. Diff. andthe location as Hospital Room 1. Also, further assume that the pathogentransmission factor 22 identifies a piece of medical equipment havingbeen tested positive for C. Diff in the last two days. Based upon acorrelation of the pathogen sample information 20 and the pathogentransmission factor 22, the control system 18 can identify the piece ofmedical equipment as possibly being the source of the spread of C. Diff.

Next, based upon the correlation of the pathogen sample information 20and the pathogen transmission factor 22, the control system 18 isconfigured to transmit pathogen action information 24 associated withthe primary pathogen sample information to an output device. While thepathogen action information 24 can be configured in a variety of ways,in one arrangement, the pathogen action information 24 is configured toinform a user about a condition regarding the pathogen sampleinformation 20, thereby allowing the user to take some action regardingthe pathogen. In one arrangement, the pathogen action information 24 caninclude information indicating a time to collect a sample, informationindicating a location to collect a sample, information indicating aprocess by which to collect a sample, information indicating a type ofsample to collect, and information indicating an instruction followingcollection, such as instructions related to the pathogen.

For example, as a result of the control system 18 receiving andcorrelating the pathogen sample information 20, the control system 18can identify the presence of a pathogen in a given location in afacility, such as in a hospital room. In such a case, the control system18 can provide, as pathogen action information 24, instructions to anend user to overcome issues raised by the presence of the pathogen. Forexample, the control system 18 can provide, as pathogen actioninformation 24, instructions to remove the pathogen from the location bycleaning or by exposing the location to UV light to kill the pathogens.Alternately, the control system 18 can provide, as pathogen actioninformation 24, instructions to select pathogen-carrying orpathogen-resistant patients or staff to access the pathogen-positivelocation. Accordingly, in the case where a pathogen is detected, thecontrol system 18 is configured to provide, as the pathogen actioninformation 24, instructions to an end user in order to remedy issuesraised by the identification of the presence of a pathogen in afacility.

In another example, with reference to the scenario provided above, inthe case where the control system 18 identifies a particular piece ofmedical equipment as possibly being the source of the spread of C. Diff,the control system 18 can provide a notice via the display device 16, asthe pathogen action information 24, that the piece of equipment may bethe source of the spread of the pathogen. Further, the control system 18can provide, as the pathogen action information 24, a modified pathogendetection schedule, pathogen cleaning schedule, and/or an identificationof the presence of the pathogen in the given room using a map of thefacility provided by the display device 16. Each of these mechanismsprovides information to a user about a condition of the pathogen sampleinformation 20, thereby allowing the user to take some action regardingthe pathogen.

As provided above, one arrangement, the control system 18 is configuredto perform a number of functions. For example, the control system 18 isconfigured to provide pathogen action information 24, such as pathogencollecting instructions as described above, to an end user via an outputdevice such as the display device 16. The collection methods, scheduleof collections and other necessary information may be pre-determined andprogrammed into the controller 21. A schedule may be determined in amanner that assures that each room is audited, for example, every threedays. If particular locations are more problematic than others, they canbe scheduled for audit more often than others. As patterns are developedand recognized through the course of the ongoing audits, the controlsystem 18 is configured to adapt and modify schedules to moreeffectively audit the facility. In some embodiments, this modificationcan be accomplished by the front-line staff responsible for remediationthrough an interactive display device, or may be the responsibility ofan infection control officer or other staff member. In some embodiments,modifications are determined by algorithms within the control system.

As with the audit schedule, collection locations within a room can bepre-selected and then modified based on ongoing audit results. Forexample, initial locations may be based on recognized Critical TouchPoints (CTP). CTPs represent areas of a facility touched frequently bymultiple people, creating conditions conducive to the spread of HAIs.Some examples of CTPs include: bed frame, TV remote, bedside table,mirror, chair arm, door knob, trash can, IV pole, sink fixture, lightswitch, toilet fixtures, TP dispenser, Blood pressure cuff, shower head,and telephone.

The control system 18 is configured to modify all aspects of collectioninstruction over time, based on audit results, to improve efficiency ofcollection and value of results.

The control system 18 is also configured to correlate the resultsobtained by the reading device 14 (i.e., the pathogen sampleinformation) with a pathogen transmission factor 22 associated with thetransmission of a pathogen within a facility. For example, the controlsystem 18 is configured to match each collected sample's result 20 withthe location and time of collection stored in a database. If specificpathogen information is included in the test, that will also becorrelated to the sample time and location.

The control system 18 is also configured to transmit and present thecorrelated information (i.e., pathogen action information 24) to thedisplay device 16. For example, the control system 18 is configured toformat the pathogen action information 24 into the desired visualrepresentation as described above, and then send it in one or moreformats to one or multiple display devices 16. In one embodiment, thecontrol system's database resides in a cloud-based system rather than ona localized computer. In this manner, the control system 18 can manageinformation from multiple facilities, and data can be correlated betweenfacilities.

Adaptive Learning

In one arrangement, the control system 18 is configured to continuouslyreceive pathogen sample information 20 from one or more reading devices.In such an arrangement, the control system 18 is configured to utilizethe information or data 20 to adjust a database of pathogen transmissionfactors 22 in order to adapt collection methods and locations based uponhistorical results (i.e. as associates with the pathogen transmissionfactors 22). This is an adaptive, self-learning system utilizingconstant feedback to maximize the ability of the control system 18 todetect pathogens. The control system 18 can adapt collecting techniquesto particular facilities or types of facilities, location within afacility, and type of room or even specific rooms and location withinrooms. It can also take into account the pathogen types and theirtraits, such as locations that they are commonly found, etc.

For example, as indicated above and with respect to a first iteration ofthe process, the control system 18 is configured to receive primarypathogen sample information 20 from a reading device 14, correlate theinformation 20 with the pathogen transmission factor 22, and transmitpathogen action information 24 to an output device. In one arrangement,with reference to FIG. 1A, following transmission of the pathogen actioninformation 24, the control system 18 is configured to receive secondarypathogen sample information 20′ related to the pathogen associated withthe facility.

For example, assume the case where the initial pathogen actioninformation 24 instructs an end user to sanitize Hospital Room 1 becausethe presence of C. Diff had previously been detected there. Followingthe cleaning process, the end user then collects a secondary pathogensample from Hospital Room 1 using the collection device 12 and providesthe sample to the reading device 14 for analysis. Following theanalysis, the reading device 14 is configured to transmit the updated,secondary pathogen sample information 20′ to the control system 18.

Based upon the secondary pathogen sample information 20′ received fromthe reading device 14, the control system 18 is configured to update thepathogen transmission factor 22. For example, assume the case where thesecondary pathogen sample information 20′ identifies the continuedpresence of C. Diff. in Hospital Room 1. Based upon such an indication,the control system 18 is configured to update the pathogen transmissionfactor 22 (e.g., the pathogen transmission factor database) to indicatethe continued presence of C. Diff in Hospital Room 1.

Next, the control system 18 correlates the secondary pathogen sampleinformation 20′ with the updated pathogen transmission factor 22, andbased upon the correlation of the secondary pathogen sample information20′ and the updated pathogen transmission factor 22, transmits pathogenaction information 24′ associated with the secondary pathogen sampleinformation to the output device, such as display device 16. Forexample, with the updated pathogen transmission factor 22 indicating acontinued presence of C. Diff in Hospital Room 1 (i.e., following thesanitization of Hospital Room 1 as instructed in the first iteration)correlation of the secondary pathogen sample information 20′ updatedpathogen transmission factor 22 can cause the control system 18 totransmit pathogen action information 24′ requiring the testing of otherequipment in Hospital Room 1 to identify a source of the C. Diffcontamination.

The control system 18 is further configured to continue the abovedescribed iterative process with subsequent secondary pathogen sampleinformation 20′ received from the reading device 14. Such a processallows the control system 18 to develop the pathogen transmissionfactors 22 (i.e., the pathogen transmission factor database) to maximizethe ability of the control system 18 to detect pathogens.

In one example, as described above, audits may start with known CTPlocations and a prescribed number of samples in a room. As results arecompiled by the control system 18, the number of samples and theirlocations can be fine-tuned so as to sample the locations most likely toreturn a positive result. If, for example, a particular locationgenerally returns a negative result, the control system 18 may limit orstop future collection at that location, and instead collect at analternative location, or eliminate that collection entirely. If aparticular location generally returns a positive result, the controlsystem 18 can add or relocate samples in future collections to locationsthat have similarities. For example, if a pathogen is found on a pieceof equipment in a room, the control system 18 may test other equipmentin the room. The control system 18 may also decide to test similarequipment in other rooms. It can be seen that this system 18 will helpto fine tune its detection capabilities to develop testing protocolsthat will sample the locations most likely to return a positive result.If the particular pathogen found is included in the data, the testingcan be tuned to test for the most troublesome pathogens.

In one arrangement, when the control system 18 is initially broughtonline, the system 18 is configured to compare and contrast the resultsof sample type, location and result (i.e., pathogen sample information20) with the pathogen transmission factor 22. As the database ofpathogen transmission factor results 22 grows, the control system 18 isconfigured to analyze the database to recognize patterns and trends inthe data 22 and to analyze patterns within patterns. As additionalinformation is entered into the control system 18, such as patientdemographics, hospital staff information, cleaning protocols used, etc.,these variables can be analyzed within the context of results for anin-depth understanding of complex interactions. As the database growsand algorithms evolve, the control system 18 can become predictive. Withthe ability to predict future trends, the system will tailor auditingmethods to find contamination at the earliest possible stage.

In some embodiments, control systems may be interlinked. This caninclude multiple control systems 18 sharing a database, or a centralizedcontrol system 18 supporting multiple facilities. One advantage ofinterlinking is that as each control system 18 evolves, it can share itslearning with the others, improving the performance of auditing at allfacilities. Another advantage of interlinking is the ability to comparepatterns and outcomes between facilities. For example, a series ofevents at one facility may have preceded an outbreak. The pattern isrecognizable and becomes part of the system's database. The controlsystem 18 can look for the beginnings of this pattern in otherfacilities and take steps to avoid an outbreak there. Interlinking cantake place within floors of a facility, between local facilities,regional facilities, or even national or worldwide facilities. These areonly examples of the benefits of interlinking.

In some embodiments, the control system 18 is configured to collectinformation about the cleaning methods and protocols that are used inresponse to a positive pathogen result. This data can be used tocorrelate the audit results with the efficacy of the cleaning methods.The employee performing the cleaning may, for example, enter cleaninginformation into the control system 18. This information may includecleaning chemicals used, method of cleaning, specific items and locationcleaned, etc. This information may be entered using any of thecommunication devices previously discussed. The control system 18 cancompare cleaning methods to audit results and build a database of themost effective responses to pathogen contamination. As the controlsystem 18 learns (i.e., builds the database with most effectiveresponses), it may display suggested cleaning methods along with thepathogen location information.

In one arrangement, the control system 18 may perform comparativeanalyses. For example, results obtained both from collecting samples(i.e., pathogen sample information 20) and from analyzing cleaningmethods can be compared between the technicians who performed thecollection and/or cleaning. If, for example, a technician's results arenotably different from the norm, it offers an opportunity to improve theresults by learning effective methods from higher performingtechnicians, and by increasing training for lower performing ones. Thesecomparisons may also be made between locations such as floors,departments, facilities, regions, etc., and by shift, day, season or anyother distinction that can help the system learn and understand thecause and effect of behavior vs. performance.

If the control system's database contains data 24 from multiplefacilities, that data can be compared and trends can be analyzed.Recognizable patterns may develop, providing an understanding of thetrends of pathogens and their spread. These patterns can be used topredict the location and type of pathogen and help to guide audits. Thecontrol system 18 may also obtain the ability to predict futureoutbreaks by recognizing a set of conditions that are conducive to anoutbreak, and therefore facilitate its prevention. This is particularlyvaluable and effective when the control system 18 is connected betweenfacilities as it may see potential problems that can affect facilitiesaround a region.

In some embodiments, the control system 18 may have access to certain ofthe facility's own data. This can be through a direct link to thefacility's electronic medical records, or by way of limited anonymousdata compiled specifically for use by the system. Data that is obtainedmay be used to determine trends by interlinking it with informationacquired during auditing. These trends are used to improve auditeffectiveness and to ultimately make predictions and conclusions thatwill aid in the prevention of HAIs and disease outbreaks. Trends can befollowed and linked geographically by room, department, facility,region, etc., demographically by patient status, diagnosis, history,etc., and chronologically by time, date or season.

In some embodiments, it can be advantageous to the control system 18 tounderstand the human and/or equipment traffic entering and exiting apatient room or other location. This may be as simple as counting thetotal number of visitors to a monitored location using a commerciallyavailable proximity detector, camera or other device capable ofrecognizing that a person or piece of equipment has passed through adoorway. In this manner, the control system 18 is configured tocorrelate the presence of pathogens to the total quantity of staff andother visitors entering the space. This correlation may show that hightraffic areas have a higher probability of pathogen contamination thanlow traffic areas. This information can be used to adapt collectionquantities, locations and techniques. The control system 18 can utilizetotal traffic counts within a time period, or look at traffic vs. timeof day to obtain and understand trends.

A traffic-identifying system may include recognition of the trafficentering and exiting the space. For example, staff member's badges mayinclude an RFID tag or other device that allows the system tospecifically identify them as they enter or exit the space. In thismanner, the system can determine any correlation between particularstaff members and pathogen presence. Visitors may be issued badges withsimilar capabilities.

The control system 18 may utilize a camera-based system. Such a systemmay include facial recognition or other techniques to identify staff,patients, visitors, etc. Additionally, people's motion may be detectedand analyzed. There are systems currently available that have theability to do this. Examples of this technology include Echo5D™ byAtlas5D™, as well as the Kinect Sensor. By including this capability,the system can determine motion within the space, and may monitorcontact between the patient and medical staff and visitors, medicalequipment and other surfaces within the patient's environment. All ofthis information may be used by the system to understand interrelationsbetween all these variables and employ the findings for the predictionof pathogen locations.

Any information obtained by the control system 18 may be used togenerate more effective auditing. This can be include adding thediagnosis of the previous patent. In this manner, audit results can becompared to patient diagnosis data. For example, after a patientdischarge, if the prior patient had MRSA, it could trigger a differentaudit protocol than if the patient had a different, or no infection. Asmore data is acquired by the control system 18, the results willcontinue to improve. This data can be patient related, such asdemographic statistics, or may be related to the facility's staff, suchas the doctor, nurses, cleaning staff and other employees. This can showtrends pertaining to specific workers. The same is true for thegeographic locations within a facility showing, for example, that aparticular room, floor, department, etc., has more or less propensityfor pathogens. Chronology can add an additional dimension of detail, astrends can be followed by time of day, season, etc.

With these factors considered, the number of samples and their locationsfor any room audit can change in real time based on the history of thatparticular room, its patients, staff and any other contributing data.The control system 18 may even be configured to take into account healthrelated information from other locations within a facility, or withinother facilities in the immediate geographical area, within the region,or even a wider area.

In one arrangement, mathematical prediction methods can be developed andimproved with practice of embodiments of the current innovation. As anexample, the control system 18 configured to execute a discriminantanalysis may be used to predict the probability of pathogen presence.This probability can then be used to determine collection location, typefrequency, etc. An example equation can be shown as: Probability ofpathogen presence=P(PP)=α+β₁X₁+β₂X₂+β₃X₃+β₄X₄ . . . , where X₁, X₂, etc.are the variables as described above and can include collection resultssuch as pathogen presence, type quantity, etc., patient demographic,staffing, cleaning protocols used, traffic and others. β values areweighting values for each of the variables. The weighting values will bedetermined and modified over time as results are correlated andunderstood. This is merely an example of the type of equation that maybe used by the adaptive, predictive control system 18. Depending uponpathogen detection results, formulas may change over time, as mayweighting values and included variables.

In some embodiments of this innovation, the control system 18 can beconfigured with the ability to direct cleaning and remediation effortsthat are determined by audit results. With knowledge of the particularpathogens that were detected and their location, specific and targetedcleaning methods can be determined. This can employ the most efficaciouscleaning chemicals and methods to use for a given pathogen on a givensurface. For example, if C. diff. is found on a bed rail, the system mayknow that the best way to remediate it is with a bleach wipe. Dependingon the pathogen to be removed and the surface on which it is found, thebest methods and cleaning chemicals can be determined. This cleaninginformation may be communicated to the staff via the display.

In some embodiments, this control system 18 can be configured to specifythe use of targeted cleaning kits. Kits can be designed that containchemicals, cleaning tools and instructions necessary for cleaning aspecific pathogen on a specific surface. In the previous example of C.diff found on a bed rail, an individually identifiable kit could containbleach wipes and instructions for cleaning. Other individuallyidentifiable kits can contain chemicals and cleaning supplies for anynumber of pathogens and surfaces. The use of kits in this manner canhelp to insure thorough disinfection and simplify the cleaning process.Additionally, the system may determine that an alternative sanitizingmethod such as room fogging or other whole-room sanitizing method wouldbe most effective.

Additional steps may be taken to assure the quality and effectiveness ofaudit results. These can be used as a method to certify collectiontechnicians, audit results and facilities. These steps are a series ofchecks and balances that add confidence to the validity of the audit.

Collection technicians can be trained and certified in the proper use ofdevices, testing methods and protocols, as well as ethical andperformance standards. Only certified staff with proper identificationmay collect samples. These staff members may be hospital employees;however, it may be preferable for them to be employees of an independentauditing company. This provides impartiality and can add confidence tothe audit results.

The control system 18 can compare audit results from the certified staffmembers. If a collection device 12 has notably different results from astatistical norm, it may be an indication of a performance problem thatneeds to be addressed. The control system 18 can look at percentage ofnegative results, amount of time taken for collections, etc. This stepprovides an additional level of confidence in the audit results.

An independent laboratory may be used to verify the results of thesystem's reader device 14. A percentage of samples that have been readmay be sent to the laboratory to be analyzed. The percentage of samplescan be a fixed amount, say 10%, can be variable based on results, or canbe determined by an appropriate statistical sampling method. Thelaboratory's results are compared to the reader device's results as onemore check on the system.

A collection device 12 may be used that contains a control sample. Forexample, the collection device 12 may contain two compartments, one forthe collected sample and one containing the pathogen being studied. Thisis can be configured as a simulated, inert version of the pathogen. Thecontrol sample should always return a positive result. If the result ofthe control is negative, it indicates that the reader is not performingcorrectly. A positive control sample result adds to the confidence ofcollected sample's result.

Pathogen Detection

Taken together, the collect and read functions of the collection device12 and the reader device 14 can form a pathogen detection system.Conventional detection methods run the gamut from simple products thatdetermine if a spot has been cleaned to sophisticated scientific methodssuch as spectroscopy and DNA testing. By contrast, embodiments of thecontrol system can use any applicable technology to detect the presenceof harmful pathogens, breaches in cleaning protocols or other indicatorsof potentially harmful conditions. Embodiments of the innovation are notdependent upon a specific technology. As improved detection methods anddevices are developed, they may be incorporated into this system.

Pathogen detection methods that can be utilized by the currentinnovation vary widely in the length of time needed to obtain results,from minutes to days. Although faster methods can be advantageous, eventhe slowest methods have value. Immediate results are not as critical tothe system's efficacy as is the value of an ongoing audit. Thecontinuing stream of pathogen data will provide an understanding of thelevel of accumulation of pathogens in terms of presence, persistence andquantity. This is particularly true in the prevention of outbreaks,since it takes a number of days for an outbreak to occur, and even theslowest methods allow for detection and remediation substantially beforethat time. With an average hospital stay of 3.6 days, results can beobtained before an infection is spread from one patient to the next.This alone can substantially decrease the occurrence of HAIs.

Even in its simplest embodiment, the current innovation can have atremendous effect on the incidence of HAIs, saving many lives andbillions of dollars. In a health care facility, where infections arecommonplace, it is often ordinary practice that the occurrence of threepatient infections triggers an action for infection control andremediation. This means that a hospital room that is contaminated with apathogen can cause three HAIs before it is attended to. An examplescenario for the current innovation will use the following assumptions:

⅓ of hospital rooms will be audited each day, meaning each room isaudited every 3rd day.

The pathogen detection test returns results in a maximum of 3 days. Thisis the slowest of the current technologies.

Audit results for each room are received every 3 days, reportingpathogen contamination from 3 days prior.

The average patient stay is 3.6 days.

The result is that even with a 3 day return of test results, on averageonly 1 patient can be exposed to pathogen contamination. That is onepatient exposure compared to the current 3 patient infections. Thismeans that the current innovation, in its simplest form, can reduce theoccurrence of HAIs in an audited room by ⅔.

To further illustrate, an example timeline will be presented:

Day 1. Audit sample (1) is collected. Later in the day, a patient isadmitted. This patient (1) is an asymptomatic pathogen carrier whosubsequently contaminates the room.

Day 4. Audit sample (1) returns a negative result. Audit sample (2) iscollected. Patient (1) is discharged. Another patient (2) is admitted.

Day 7. Audit sample (2) returns positive for pathogens. Patient (2) hasbeen exposed, but may not yet be symptomatic (It can take from 2 days toover a week for incubation). If patient is deemed susceptible,antibiotics may be started. The room is remediated.

This nearly worst-case scenario illustrates that the current innovation,even in its simplest form and using the slowest test methods, can beextremely effective. Even though patient (2) was exposed, the exposurewas detected prior to the patient's discharge. Treatment can begin, andthe patient can be discharged on schedule. Without the knowledge gainedfrom the audit, this patient could have been discharged and becomesymptomatic after returning home, resulting in a costly readmission. Thedelay in treatment may have resulted in a severe infection, causing alengthy stay in the hospital, or even death. Additionally, without thecontinuing audit, two additional patients may have been infected priorto remediation.

Table 1 shows the above scenario along with modifications andillustrates the effect of collecting samples more frequently and usingtests that can return a result in one day. The results in bold indicatepositive results. All results are based on an average length of stay. Aswould be expected, the best results occur when the room is sampled everyday using a test with a one day result time. In this case, pathogencontamination is discovered prior to patient 1 being discharged. Theother scenario that, on average, may return a positive result prior topatient 2 being admitted is to sample every two days with a one day testresult (depending on the time of day that the result is received). Allthe other results are received between one and four days after patient 2is admitted.

TABLE 1 sample frequency (days) 3 3 2 2 1 1 result time (days) 3 1 3 1 31 Day 1 sample 1 sample 1 sample 1 sample 1 sample 1 sample 1 patient 1admitted 2 result 1 result 1 sample 2 sample 2 result 1 3 sample 2sample 2 result 2 4 sample 2 sample 2 result 1 result 2 result 1 patient1 result 1 discharged patient 2 admitted 5 result 2 sample 3 result 2 6result 2 7 sample 3 result 2

The above scenario does not take into account additional factors.Current research shows that the probability of a patient becominginfected by contamination in a room appears to be related to thepercentage of surfaces within that room that are contaminated.Additionally, the quantity of bacteria present on a contaminated surfacecontributes to the probability of the pathogen being spread. The moremassive a bacteria colony is, the more likely it is to be contacted andto cause infection. The opportunity for the spread of contaminantsincreases with time as the patient, visitors and staff touch multiplesurfaces, depositing and/or spreading pathogens, and pathogen colonieshave time to grow. The length of time it takes for the contaminationlevel to reach a point of high probability of transmission is variableand uncertain, but it may take days to weeks for the level to becomecritical. This makes the current innovation even more effective becausepathogens may be found by an audit before having enough time to spreadand grow, creating a high probability of infecting a patient. Even witha 3 day audit result, many pathogens will be found and remediated whentheir levels are low and not likely to cause infection.

The choice of sample frequency, and the resulting cost increases will bedetermined by factors such as staffing levels, costs of testing and,mostly, effectiveness as determined by the evidence produced by thescientific audit. The choice of sampling frequency and protocols for aparticular facility or location within a facility may involve additionalfactors. Some areas, such as day surgery, emergency rooms, urgent carefacilities, etc. will have a shorter length of stay than the 3.6 dayaverage, as well as exposure to more patients. It may be advantageous tosample more frequently and/or choose more rapid detection methods inthese areas. In contrast, a chronic or other long term care facility maynot need to be audited as often. Facilities that work largely withpatients that have compromised immune systems, such as oncology, canrequire more frequent audits than a physical therapy department thatworks with injured, but generally healthy patients. These areillustrative examples, and not an exhaustive list. Any factors thatcontribute to the spread of pathogens and resulting infections may betaken into account.

With most technologies currently available, a detection method cangenerally test for only one type of pathogen. The particular pathogenbeing audited must be determined prior to testing. For example, C. diff,which may account for as much as 30% of HAIs, may be of particularinterest within a facility. Even if this were the only pathogen beingtested for, the system would still be effective. Where C. diff is found,there are likely to be other pathogens. Additionally, C. diff is adifficult pathogen to remove. If an area has been cleaned well enough toremove C. diff, then most other pathogens have also been removed.Because of this, the result of testing for C. diff alone can besubstantially greater than 30%.

Testing for specific pathogens may be location dependent. If a facility,or location within a facility, historically shows a more significantoccurrence of a different type of infection, for example MRSA, then itmay be more effective to sample for that pathogen. The selection ofpathogens to test may also change with time, as different ones becomepredominant. Audits may be chosen based on historical information, forexample, if a room's prior patient had an infection that may cause anHAI, the next audit for that room may test for that specific pathogen.Numerous testing methods can be developed as the auditing system isused. For example, target pathogens may be alternated during subsequentaudits, or more than one target pathogen may be sampled in an audit. Astesting technologies become available that can sample for multiplepathogens, they can be incorporated into the current system.

Patient Perimeter

A patient may contact environmental pathogens by touching surfaces,people or other items that are contaminated. Accordingly, importantlocations to sample are those within the patient's reach. A patient'scondition may be taken into account by the system in order to refinesampling by defining a patient perimeter. A patient who is confined to abed can only reach a limited distance, and so has a small perimeter inwhich to make contact with pathogens. In one arrangement, the system canconfine sampling to locations within reach of the patient, such as thebed, table, IV pole, night stand, telephone, TV remote, etc. A patientwith limited mobility may get out of bed only to use the bathroom.Knowing this, the control system 18 may expand the perimeter to includeany surfaces or objects between the bed and bathroom, as well as insidethe bathroom itself. In the case of an ambulatory patient, the perimetermay expand to include the entire room. In a unit with ambulatorypatients, the patient perimeter may expand to encompass hallwaysurfaces, equipment, etc. FIGS. 10A and 10B depict a hospital room.Within it are the bed 1001, table 1002, stand 1003 and bathroom 1004.For the bedridden patient, the patient perimeter may be defined as shown1005 in FIG. 10A. For the patient with limited mobility, it may bedefined as shown 1006 in FIG. 10B. For the ambulatory patient, theentire room may be defined as the perimeter.

In one arrangement, the control system 18 is configured to define apatient perimeter 25 as a pathogen transmission factor 22 associatedwith a patient location within a facility, such as based upon theabove-referenced criteria. Defining the patient perimeter allows thesystem 10 the ability to perform the most effective and cost-efficientsampling possible. For example, the control system is configured totransmit pathogen action information 24 to an output device based uponthe correlation of the pathogen sample information 20, the pathogentransmission factor 22, and the patient perimeter 25. By defining theperimeter, the pathogen action information 24 can indicate that areasthat are not likely to infect a patient are not sampled, saving time andcost. In a smaller perimeter with less area and surfaces, it may be anadvantage to sample a higher percentage of surfaces to increase theconfidence of the results, since a sample area with a small perimetermay take less time and fewer collection samples. In many cases, a smallperimeter may indicate a compromised patient with a weak immune system.More concentrated sampling can give a higher confidence of apathogen-free environment. As a patient's status changes, the system mayadjust the patient perimeter to suit. For example, a patient perimetercan be classified based on mobility and/or on diagnosis. The patientperimeter can also change with time.

In a room that contains more than one patient, the control system 18 mayconsider the status of all patients when determining appropriatesampling methods and locations.

FIG. 11 shows one example of a double room in which both patients areambulatory. The patient in the first bed 1101 has a patient perimeterdepicted by the solid line 1102. The patient in the second bed 1103 hasa perimeter depicted by the broken line 1105. The area where the twopatient's perimeters overlap is shown by hatch lines 1106. Theoverlapping area includes the bathroom and the aisle in front of thesecond bed. The control system 18 may determine that the overlappingarea requires more stringent auditing then the non-shared areas. Thismay include sampling more area of the surfaces, sampling additionalsurfaces, testing for multiple pathogens, more frequent auditing, etc.Other factors may be included in sampling decisions. For example, sinceall persons entering or exiting the room must pass through part of theperimeter of the patient in the second bed, additional or alternativetesting may be conducted in that patient's area. The health of theindividual patients or even the previous patient's diagnosis may beincorporated by the system for use in determining sampling techniques.These are only examples of the use of a patient perimeter as an elementin determining sampling techniques and frequencies. These methods may beused with rooms with more than two patients, with alternative roomlayouts and floor plans, or in combination with any other methodsdescribed in this disclosure.

Other perimeters may also be defined, such as hallways and common areas,diagnostic rooms, etc. These perimeters will be defined as zones. Thezones in this example are not a complete list, but are useful toillustrate aspects of this innovation. Zones may be added, subtracted ofchanged as needed, depending on an individual facility, type oftreatment, etc. For this example, zones will be defined as:

Zone 1: perimeter of a bedridden patient (1005 in FIG. 10A)

Zone 2: perimeter of a patient with limited mobility (1006 in FIG. 10B)

Zone 3: perimeter of an ambulatory patient; the entire room, includingbathroom

Zone 4: areas shared by more than one patient (1106 in FIG. 11)

Zone 5: unit hallways and common areas

Zone 6: diagnostic or treatment areas (X-Ray, PT, etc.)

These zones may be used in a patient centered approach to determine whenand where to collect samples to most efficiently and effectively findand aid in the removal of pathogens. A patient can be classified as aZone 1, 2, or 3 patient as described above.

An auditing protocol may be defined for each zone. For example, a Zone 1auditing protocol (AP1) will order samples to be collected on thecritical touch points within reach of a Zone 1 patient. In embodimentsutilizing an adaptive system as described previously, the samplingpoints may change with time, based on the results of previouscollections. A Zone 3 auditing protocol (AP3) will include samplelocations within the entire room and bathroom. This is similar for allzones. Some embodiments may include multiple protocols for each zone.There may be a standard protocol along with an enhanced protocol thatincludes more detailed sampling or pathogen-specific sampling based on apatient's susceptibility, sample result history or other factors. Forexample, a standard Zone 1 audit protocol may include sampling a totalarea of 20 square inches on the bedrails, table and IV pole. If a Zone 1audit tests positive, the system may trigger an enhanced audit protocolthat samples 50 square inches of surface on the standard audit surfacesplus others. If a patient being admitted is deemed to have a highsusceptibility of infection, or if the prior patient had an infection,it may also trigger an enhanced or expanded audit. There can be multipleaudit protocols for each Zone that are targeted to specific pathogens,patient susceptibilities, prior history and other factors.

In some embodiments, the system can initiate a remediation protocolbased on audit results. Cleaning and sanitizing protocols can bedeveloped for each zone. For example, a Zone 1 remediation protocol(RP1) will encompass the cleaning methods, tools and cleaners necessaryfor an intensive sanitizing within that zone. This is similar for allzones. There may be more than one protocol for each zone. The choice ofprotocol may be based on the specific pathogen found or otherparameters. Additionally, enhanced protocols with more rigorousremediation techniques may be used in Zones that have a persistent orlarge volume contamination.

In some embodiments, the materials and supplies for each auditing and/orremediation protocol may be prepared in kit form. For example, thesystem may instruct the user to acquire an AP1 kit and proceed to aspecific room to collect samples. The AP1 kit may include collectiondevices 12 and instructions necessary to take samples in Zone 1 of thatroom. Similarly, the system may send an instruction to acquire a RP1kit, containing the necessary chemicals, supplies and instructions, andproceed to a specific location to perform a remediation.

The flow chart 1700 in FIG. 17 shows a decision path for each of thezones. This example shows both auditing and remediation responses,however some embodiments may include auditing only. For simplicity, onlyone auditing protocol and one remediation protocol is shown for eachzone. These are simplified examples. It may be preferable to includeadditional factors in the decision tree. These may include patientdiagnosis, pathogen results and history, multiple protocols for eachzone, etc.

Referring now to FIG. 17, each patient's zone is defined as Zone 1, 2 or3 as described above. For a Zone 1, or bedridden patient, AP1 isdeployed. A negative result indicates there is no pathogencontamination. In this case, the standard auditing schedule iscontinued. A positive result indicates the presence of pathogens, whichcan require further action. It may be important to know if the patienthas left the unit, for example has been transported for X-Rays, physicaltherapy, etc. If the patient has been to another location, it may benecessary to test that location to determine whether pathogens have beencarried there by the patient. If so, the system can order the deploymentof AP2 (expanding to the next zone) and AP6 (the visited location). Ifthe patient has not left, then only AP2 is necessary. At this point, RP1may be deployed to remediate any pathogens in Zone 1 of the patientroom. If the sample results are negative, the standard audit is resumed.If the results are positive, the audit area is expanded to Zone 3,remediation expands to RP2, and if positive at the remote location, RP6.Negative results always return the system to the standard auditingprotocols. Positive results can trigger expanding sample and remediationzones.

For a Zone 2 patient, with limited mobility, the control system 18 mayinquire whether the patient is in a shared room. If so, then Zone 4 (theshared space) can be included in the auditing and, if necessary,remediation protocols. For a Zone 3 ambulatory patient, the standardaudit zone is expanded to the entire room SP3. Since this patient hasaccess to more spaces, a positive result may require auditing andremediating the unit hallways and common areas.

These examples show only one timeline that may span multiple days. Thestandard auditing procedures may test each room daily, every 2 days,etc. For each patient or room, there may be multiple timelines atvarious points in their progression. The results from one timeline maybe used as a factor in making auditing and remediation decisions inconcurrently occurring timelines.

Detection Technologies

Following is a synopsis of several conventional pathogen detectiontechnologies. The current innovation may incorporate one or more ofthese, or other, pathogen detection technologies.

ATP tests can reveal biomass left on a surface, and results areavailable in minutes. A disadvantage with ATP testing is that itindiscriminately detects biomass and cannot tell the difference betweenliving or dead cells, or whether a detected biomass is harmful orbenign. This can result in a great deal of cleaning effort to removeharmless substances. Another technology would recognize and possiblyidentify and classify pathogens.

One conventional method used in healthcare facilities is to culturesamples taken within a room that is suspected of being contaminated. Anarea is swabbed for a sample, which is then placed into a growth mediumsuch as agar. The sample is incubated at an elevated temperature andobserved for bacteria growth. Various growth media and techniques may beused to test for a variety of pathogens. As the pathogen colonies grow,the morphology of the growing colony is observed and the type of microbeis determined. Initial results can begin to be seen in approximately sixhours, but it can take up to 48 hours to make a positive identification.This method relies on the experience of the observer to make a correctidentification. It can, however, obtain detailed information about thetype of pathogen found.

Gram staining is a conventional method of classifying bacteria. This isa manual process in which a sample is prepared and then viewed under amicroscope. The multi-part preparation includes smearing the sample ontoa slide, covering with crystal violet, rinsing, covering with Gram'siodine (mordant), draining then rinsing the slide in 95% ethyl alcohol,rinsing, covering with safranin (counterstain), rinsing and blotting.The prepared sample is viewed under the microscope, and bacteria areidentified by color and shape, and are classified by gram positive orgram negative. Gram positive bacteria stain violet and include Bacillus,Listeria, Staphylococcus, Streptococcus, Enterococcus, and Clostridium.Gram negative bacteria stain red, and can include E. coli,acinetobacter, Klebsiella pneumonia and others that result in many typesof HAIs, including pneumonia, urinary tract infections, and bloodstreaminfections.

Liquid chromatography-mass spectrometry can be used to identifymicroorganisms. A sample is first separated by liquid chromatography,where a pressurized liquid and a sample mixture are pumped through acolumn filled with a sorbent, which separates the sample components. Thecomponents are then analyzed by the spectrometer, which breaks down thelight emitted or absorbed by chemical elements into specific lines ofcolor. Every chemical element on the periodic table has its own spectralfingerprint that identifies it, so the chemical compounds can beidentified. In two of the more commonly used methods, Raman spectroscopymeasures the scattering of light, while infrared spectroscopy is basedon absorption of photons. This technique is rapid and accurate, but theequipment is very expensive, costing $80K and up per unit.

DNA testing can be used to identify microbes. One method of DNA testingutilizes a CCD camera for Surface Plasmon Resonance imaging (SPRi). Thisis an optical process used to detect the binding of molecules ontoarrays of probe biomolecules attached to chemically-modified goldsurfaces. In basic terms, the camera looks at light refracted through aprism and a computer creates a DNA image from the information.

In one arrangement, optics-based instant read scanning devices can alsobe utilized. For example, optics based devices can illuminate a microbewith specific wavelengths of light and detect optical phenomena specificto pathogens.

Collection Device

Accuracy and consistency of sample collection is critical to obtaininglegitimate pathogen testing results. Some embodiments of this innovationmay utilize a sample collection device 12 that will assist the user incollecting samples at the correct locations, at the correct time, andwith proper collecting techniques

FIG. 12 shows an example collection system 1200 having a collectiondevice 1201 and a replaceable collector 1202. In one arrangement, thecollection device 1201 includes a user computerized device, such as asmartphone 1203 and a smartphone housing 1204. A commercially availablesmartphone, such as an iPhone, Android, etc., may be used, since thesedevices contain many of the features that will aid in collectingsamples. However, a custom designed device could also be used. Thesmartphone 1203 may be inserted into the housing 1204 in the same manneras it is inserted into a protective case. The housing 1204 allows theuser device 1203 to interface with the replaceable collector 1202 andmay contain additional electronic and/or mechanical components andconnections.

The replaceable collector 1202 contains a swab component (not visible inthis view) that is wiped on the surface being sampled. The collector1202 comprises a body 1205 with an attaching means 1206 to removablyattach it to the housing. In this example, the collector body 1205 has ahinge 1207 that allows the body to open, exposing the swab. In oneembodiment, the collector 1202 is automatically identifiable by thecollecting device 1200. This example utilizes a bar code 1208 that canbe read by the smartphone. Other identifiers may be used, such as QRcodes, RFID or other suitable technology. The shape, attaching mechanismand other details of the collector 1202 are exemplary and not meant tobe limiting. Other designs can function as well within the scope of thisinnovation.

FIGS. 13A through 13C illustrate the progression of the attachment ofthe collector 1202 to the computerized device housing 1204. In thiscase, a tab 1301 mates with the slot 1206 in the collector 1202. In theview illustrated in FIG. 13C, the collector 1202 is fully inserted andattached to the housing 1204.

FIG. 14A shows the underside of the collection device 1200. In thisembodiment, the smartphone's camera 1401 can read the barcode 1208 onthe collector 1202. Since each collector 1202 has a unique identifier,the device 1200 will be able to match the specific collector to the timeand location of sampling.

As illustrated in FIG. 14B, the collector body 1202 has been opened atthe hinge 1207 to expose the swab surface 1402. A seal 1403 may beincorporated into the collector body 1204 to keep air and moisture awayfrom the swab both prior to and after sampling and insure that anypathogens within the sample are captured. In one embodiment, the cameraretains visibility of part of the collector when it is open. In thismanner, the device insures that the collector is not only open and readyfor sampling, but is still present.

The material of the swab 1402 may be chosen depending upon the specificpathogen being tested. Commonly used materials are cotton, PET andpolyester. The collection device 1202 may also contain a neutralizingbroth additive that neutralizes residual sanitizers that may be presenton a surface. Swab materials and additives are well known in the art andwill not be discussed in detail. In some embodiments, one collectiondevice 1200 may be used to test for different pathogens, depending onthe type of growth media used in processing the collected sample. Onesample may also be used to test for multiple pathogens by splitting thesample between growth media. Additionally, a control sample may becontained within the collection device 1200. This can be an inertversion of the pathogen being tested. There may be collection devices1200 of differing types with materials and additives selected forspecific pathogens of interest. The collection device 1202 to be usedmay be chosen by the type of pathogen being studied. Since allcollection devices 1200 are individually identified, the device candetermine whether the correct collector is being used.

FIG. 15 shows the collection device 1200 in position ready to sample ahorizontal surface. FIG. 16 shows an embodiment of the collection device1200 with a retractable handle 1200 that is lowered to allow a user tograsp and maneuver the collection device 1200 during a sample collectionprocedure.

The collection device 1200 performs many functions that aid in accurateand consistent sampling. In one scenario of its use, the technicianturns on the device and logs on to the detection and display system 10.This may be a manual login, but is preferably an automatic recognitionof the technician. This can be accomplished in ways that includescanning a bar code, QR code or other identifier that is on thetechnician's identification badge. Many user devices are configured withthe ability to read finger or thumb prints, or perform retina scans.This offers a positive identification of the person using the device.

Once logged onto the detection and display system 10, the collectiondevice 1200 receives sampling instructions from the pathogen displaysystem's controller. The sampling device can now pass these instructionsto the user through the audio and video capabilities of the device'ssmartphone. Instructions may include which room or area will be sampled,where within the area to sample, which collection device 1202 to use,when a sample has been correctly taken and other information. Thescenario may go as follows:

The technician turns on the collection device 18 and logs into thedetection and display system 10 via thumbprint scan, etc.

The technician is instructed by the control system 18 to go to aparticular space within the facility.

The technician is instructed by the control system 18 to attach acollector 1202 to the device 1200. In cases where there is more than onetype of collector available, the type will be specified. The device 1200identifies the collector as being an unused collector of the correcttype, and records the identifier.

The technician is instructed by the control system 18 to open thecollector, exposing the swab portion. The device confirms that thecollector is ready to swab.

The technician is instructed by the control system 18 to take a samplefrom a specified location. In some embodiments, the device utilizes thesmartphone's onboard GPS, accelerometer and orientation capabilities. Byusing these capabilities, the control system 18 can determine the exactlocation of the sample, the velocity at which the sample was taken andthe angle of the device in two axes.

Some embodiments may include a force measurement. This can beaccomplished by including a force sensor in the device housing andtransmitting the data to the smartphone. Alternatively, certainsmartphones are configured with pressure sensitive displays, the onboardsensor may be used. The technician can be instructed to hold the deviceand press on a location on the display to apply pressure to the swab.The pressure on the display can be used to calculate the actual force onthe swab.

With this information, the device 1200 can assure that the sample wastaken at the correct location and sampling area, that the swab passedover the surface at the optimal sampling velocity, that the anglecorresponds to the orientation of the surface being sampled, and thatthe optimal amount of force was put on the swab. If any of these sensedsampling parameters are not optimal, the device can give the technicianinstructions to correct their technique. The device may even give thetechnician a score on their performance, for example 1-10, for immediatefeedback on the quality of their sampling technique.

Once a sample is complete, the device 1200 can instruct the technicianto close the collector 1202 and remove it from the device 1200. It mayalso instruct the technician as to what to do with the used collector.

The sample is now complete. The device can instruct the technicians totake another sample within the area, move to a new area, etc.

Reading System

Some embodiments of the innovation may include a system that samples andcultures potentially harmful microbes within a health care environment,and identifies and categorizes pathogens. This uses a method thatautomates certain culturing operations and methods, as described above,and manages others to create a complete solution for the detection andclassification of harmful pathogens.

Bacteria, spores, etc. that are collected during the sampling processare microscopic. In order to facilitate visual recognition, they areallowed to grow into a colony. This is accomplished by placing thesample into a growth medium such as agar or nutrient broth, thenincubating at an elevated temperature to promote growth. In general,visible growth occurs within six hours, although it can take up to 48hours to positively identify a microorganism and its strain. Theparticular growth media will be selected based on the types of pathogensof interest, e.g. MRSA, C. diff, acinetobacter, etc. In someembodiments, more than one growth medium may be used, and the sampletested for multiple pathogens.

An imaging camera can be used to monitor and survey sample growth overtime. Images of the samples may be captured and stored over time. Thiscamera may be visible-light, infrared or a combination. The type ofcamera used will depend on the specific pathogens of interest and atwhat wavelength of light they are most easily visible.

An objective lens may be used to focus the image of the growing culture.This may be a stationary fixed-focus lens, or may comprise an adjustablefocus. If an adjustable focus lens is included, it can be used tomeasure the height of growth of the colony (by focusing top and bottomof the colony and measuring distance) if this information is deemeduseful in identifying a pathogen.

Illumination of the sample may also be selective. For example, if aparticular pathogen reflects one wavelength of light better thananother, a light source that produces that wavelength may be used. Thepreferable light source is one or an array of LEDs, since they areavailable to produce a variety of colors. An array may be used toproduce a multiple of specific wavelengths that can be used singularlyor in combination to facilitate the visualization of multiple pathogens.

The system includes a computerized device, such as a computer systemhaving a controller such as a memory and a processor, to identifypotentially harmful pathogens. As microbe colonies grow, they developwith recognizable patterns. These patterns can be used to identify themicrobes. The computer system contains a database comprising images ofall microbes of interest. This database can be modified as new speciesof microbes emerge. The computerized device is configured to compare theimage captured by the camera to images in the database and determinesmatches. The camera and computer are configured to automatically performthe same function that a morphologist performs when manually testingsamples. The current innovation has the advantage of automation,infrared imaging, adaptive lighting and a nearly infinite library ofpathogens and other organisms. The library may contain images ofpathogens at varying stages of their growth to aid in earlyidentification. The library may also contain non-pathogenic microbeimages that may be used to eliminate samples that are not of interest.

The computerized device is configured to compare the visible image tothe database and looks for matching patterns. In samples with activemicroorganisms, growth should start to be visible within approximatelysix hours. If after six hours there is no growth, then there are nomicroorganisms within the sample. The computerized device can then stopthe comparison and save the results as a no growth culture. This is doneon an ongoing basis until the pattern is developed enough to make apositive or negative identification. Once a microbe has been identified,the results are reported. The computerized device is also configured tomeasure the size of the colony. The size may be measured as square areaor cubic volume and mass may be calculated from the volume. In thismanner, the system has the ability to determine both the type and colonysize of the pathogen.

Once the microbes that have been identified are analyzed and classifiedby the computerized device, the results can be reported as:

No growth: if no growth is seen within the prescribed time, no microbesare present.

Growth not of interest: microbial growth is present, but the microbesare not harmful.

Harmful pathogen: microbes are present, and are deemed to be harmfulpathogens.

Results uncertain: growth is present, but a positive identificationcould not be made.

The control system 18 is configured to learn as test results areobtained in order to accelerate the identification process. Images areobtained throughout the growth process, and the system can look forsimilarities in growth patterns. Early tests may take 24 to 48 hours toreturn a positive identification. However, growth of a particularmicrobe may follow a unique pattern that allows the system to recognizeit prior to it being developed enough for a visual recognition. Primaryobservations may be made by the system such as color, shape, size,growth rate, luminescence, etc., as well as more subtle observationssuch as rate of change of the primary observations. The ability torecognize a particular pattern of growth prior to the development of anidentifiable growth will allow identification to be made earlier in thegrowth process. This automated system will have the ability to recognizemultiple patterns during the growth process, allowing identification ofmultiple microbes in a sample.

FIG. 18 shows a schematic representation of the components within areading system 1800. The reading system 1800 includes a camera 1801,such as the imaging camera described above. This may be a visible lightor infrared camera 1801, or a combination camera. While a single camera1801 is illustrated, the reading system 1800 can include multiplecameras. These may be fixed or variable focus, depending on the detailof readings desired.

The reading system 1800 can include a lighting device 1802 configured toproject single or multiple light frequencies, and may one, two or anarray of lights. A holding device 1803 holds collectors containingsamples to be determined. In some embodiments, the holder device 1803holds multiple collectors, for example, in a carousel device. If acarousel device is used, the reading system 1800 can include a turntable1804. The reading system 1800 also includes a computerized device (notshown) having a controller such as a processor and a memory or othersuitable control device. The controller is configured to operate thecameras and lights, as well as the turntable and any other devices thatare part of the reader, contains software that compares and determinespathogen content, and communicates with the pathogen display system'scontrol system. It also has access to the pathogen database. The readingsystem 1800 may have a stand-alone control system, or may share part orall of its functions with the pathogen display system's control system.

FIG. 19 shows an example of the carousel device 1901. A collector 1902is disposed within the carousel device 1901. The carousel device 1901shown has space for 8 samples. A carousel device 1901 may have more orless spaces as determined by design intent. A reading system 1800 may beable to accept multiple carousels and include an indexing means.Alternatively, the reader system 1800 may use mechanisms other than acarousel device 1901 to hold one or multiple collectors.

In use, the reading system 1800 is configured to move a selectedcollector 1902 into position to be viewed by the camera 1801. Thereading system 1800 can read the identifier on the collector 1902, whichwill correlate it to the sample location and time. This minimizes oreliminates the possibility of intermixing samples and producingincorrect results. Since each collector's results take several hours,the reader can cycle each collector into view in an intermittentfashion. As each sample reaches the point at which a determination ismade, the result is logged and may be displayed. In some embodiments,the reader includes a mechanism that removes a collector that has beencompleted and replaces it with another untested one.

Certification

The systems, methods and apparatus described herein may be used a meansto certify a pathogen auditing program. This certification may beconsidered on four levels. The flowchart 2000 in FIG. 20 illustratesthese certification levels.

Level 1 certifies the technician. This assures that the collectiontechniques used by all technicians are correct and consistent. Thisbegins with a vetting process for each technician to confirm that theyhave the necessary skills and abilities to understand and carry outsuccessful collections. The specific skills required will be determinedwith practice of the art. All technicians will undergo intensive initialtraining, as well as ongoing training, to certify them in the proper useof devices, testing methods and protocols, as well as ethical andperformance standards.

Level 2 certifies the collection of samples. This certification levelassures that samples are taken in the specified locations, at thespecified times, using the correct methods and techniques. This beginswith technicians that are certified at Level 1. The system presents aset of collection instructions to the technicians who are proficient atcollection techniques, protocols, etc. These collection locations andmethods have been determined by the system to be the most likely to findpathogen contamination. The proprietary collector adds another layer ofassurance to the certification. The collector recognizes the technicianand monitors their movements, sampling location and sampling technique.If samples are not collected as expected by the system, it can instantlyinstruct the technician with corrections. This aids in removing humanerror from the system.

Level 3 certifies the audit results. This begins with the Level 2certified collections. An independent laboratory review adds anotherlayer of certainty to the results, as does the control sample asdescribed above. Comparing results between technicians adds one morelayer of control. Technicians whose results vary from the norm can bereviewed to understand the differences and actions may be taken to bringthem into compliance. As an adaptive system, sampling instructions areconstantly being reviewed and revised based on historical results in aneffort to create a constantly improving result. Embodiments that utilizethe proprietary reader add an additional level of confidence. As withthe collector, this device aids in removing human error as a factor indetermining pathogen content.

Level 4 certifies the facility. At this level, entire facilities, orselect units within a facility, enroll in a continuous auditing program.The nature of pathogen spread and growth is unpredictable andchangeable. It is important that Level 3 audits are conducted in anongoing manner to truly understand the circumstance of pathogens withina facility. The data produced by these audits has a cumulative learningeffect on the adaptive systematic audit protocols that are created bythe system. This certification can be enhanced as multiple facilitiesjoin the system and share.

While various embodiments of the innovation have been particularly shownand described, it will be understood by those skilled in the art thatvarious changes in form and details may be made therein withoutdeparting from the spirit and scope of the innovation as defined by theappended claims.

What is claimed is:
 1. In a control system of a detection and display system, a method of providing pathogen action information to a user, comprising: receiving, by the control system, primary pathogen sample information related to a pathogen associated with an environmental surface of a first location of a facility, the primary pathogen sample information identifying a size of a pathogen colony associated with the pathogen and present on the environmental surface; correlating, by the control system, the primary pathogen sample information with a pathogen transmission factor, the pathogen transmission factor associated with transmission of the pathogen within the facility; based upon the correlation of the primary pathogen sample information and the pathogen transmission factor, transmitting, by the control system, pathogen action information associated with the primary pathogen sample information of the environmental surface at the first location of the facility to an output device; following transmission of the pathogen action information, receiving, by the control system, secondary pathogen sample information related to the pathogen associated with the environmental surface of the first location of the facility, the secondary pathogen sample information identifying the size of the pathogen colony associated with the pathogen and present on the environmental surface; updating, by the control system, the pathogen transmission factor based upon the secondary pathogen sample information; when the secondary pathogen sample information identifies one of a negative result at the environmental surface of the first location of the facility, the negative result indicating an absence of pathogen contamination at the environmental surface of the first location, and a positive result at the environmental surface of the first location of the facility, the positive result indicating a presence of pathogen contamination at the environmental surface of the first location, executing, by the control system, a discriminant analysis based upon the updated pathogen transmission factor to predict a probability of pathogen contamination at an environmental surface of a subsequent location of the facility; based upon the predicted probability of pathogen contamination at the environmental surface of the subsequent location of the facility, transmitting, by the control system, pathogen action information related to the subsequent location of the facility to the output device; and displaying, by the control system, a graphical representation of a map of the facility on the output device and identifying the location of the first location within the facility, the location of the subsequent location within the facility, and the predicted pathogen contamination at the environmental surface of the subsequent location by highlighting the location of the first location within the facility, highlighting the location of the subsequent location within the facility, and highlighting the predicted pathogen contamination at the environmental surface of the subsequent location on the graphical representation of the map of the facility.
 2. The method of claim 1, wherein the primary pathogen sample information is configured as at least one of a pathogen sample type, a pathogen sample collection time, and a pathogen sample collection location.
 3. The method of claim 1, wherein the secondary pathogen sample information is configured as at least one of a pathogen sample type, a pathogen sample collection time, and a pathogen sample collection location.
 4. The method of claim 1, wherein the pathogen action information is configured as at least one of: information indicating a time to collect a sample; information indicating a location to collect a sample; information indicating a process by which to collect a sample; information indicating a type of sample to collect; and information indicating an instruction following collection of a sample.
 5. The method of claim 4, wherein the information indicating the instruction following collection is configured as an instruction related to the pathogen.
 6. The method of claim 1, comprising: defining, by the control system, a patient perimeter as the pathogen transmission factor, the patient perimeter associated with a patient location within the facility; and wherein transmitting, by the control system, pathogen action information associated with the primary pathogen sample information to the output device comprises transmitting, by the control system, pathogen action information associated with the primary pathogen sample information to the output device based upon the correlation of the primary pathogen sample information, the pathogen transmission factor, and the patient perimeter.
 7. The method of claim 1, comprising: defining, by the control system, a patient perimeter as the pathogen transmission factor, the patient perimeter associated with a patient location within the facility; wherein the pathogen action information identifies arcas environmental surfaces relative to the patient perimeter that are excluded from a pathogen sampling procedure.
 8. The method of claim 1, wherein: receiving subsequent secondary pathogen sample information related to the pathogen associated with the environmental surface of the first location of the facility comprises receiving, by the control system, secondary pathogen sample information in a substantially continuous manner; and updating the pathogen transmission factor based upon the subsequent secondary pathogen sample information comprises adjusting, by the control system, a database of pathogen transmission factors to adapt collection methods and locations based upon historical results.
 9. The method of claim 1, further comprising repeating an audit process of: receiving, by the control system, subsequent secondary pathogen sample information related to the pathogen associated with the environmental surface of the subsequent location of the facility; updating, by the control system, the pathogen transmission factor based upon the subsequent secondary pathogen sample information; when the subsequent secondary pathogen sample information identifies one of a negative result at the environmental surface of the subsequent location of the facility, and a positive result at the subsequent location of the facility executing, by the control system, a discriminant analysis based upon the updated pathogen transmission factor to predict a probability of pathogen contamination at another subsequent second location of the facility; and based upon the predicted probability of pathogen contamination at the environmental surface of the subsequent location of the facility transmitting, by the control system, pathogen action information related to the another subsequent location of the facility.
 10. The control system of claim 1, wherein the size of the pathogen colony comprises at least one of an area of the pathogen colony, a volume of the pathogen colony, a mass of the pathogen colony, and a percentage of the environmental surfaces contaminated with pathogen.
 11. The control system of claim 10, wherein the percentage of the environmental surfaces contaminated with pathogen relates to one of a percentage of surfaces tested and an extrapolation of a test sample of an environmental surface location.
 12. A pathogen detection and display system, comprising: a collection device configured to retrieve a sample from a facility; a reading device configured to receive the sample from the collection device, to process the sample, and to generate pathogen sample information related to the sample; a control system disposed in electrical communication with the reading device; and an output device disposed in electrical communication with the control system; wherein the control system is configured to: receive, from the reading device, primary pathogen sample information related to a pathogen associated with an environmental surface of a first location of a facility, the primary pathogen sample information identifying a size of a pathogen colony associated with the pathogen and present on the environmental surface; correlate the primary pathogen sample information with a pathogen transmission factor, the pathogen transmission factor associated with transmission of the pathogen within the facility; based upon the correlation of the primary pathogen sample information and the pathogen transmission factor, transmit pathogen action information associated with the primary pathogen sample information of the environmental surface at the first location of the facility to the output device; following transmission of the pathogen action information, receive, from the reading device, secondary pathogen sample information related to the pathogen associated with the environmental surface of the first location of the facility, the secondary pathogen sample information identifying the size of the pathogen colony associated with the pathogen and present on the environmental surface; update the pathogen transmission factor based upon the secondary pathogen sample information; when the secondary pathogen sample information identifies one of a negative result at the environmental surface of the first location of the facility, the negative result indicating an absence of pathogen contamination at the environmental surface of the first location, and a positive result at the environmental surface of the first location of the facility, the positive result indicating a presence of pathogen contamination at the environmental surface of the first location, execute a discriminant analysis based upon the updated pathogen transmission factor to predict a probability of pathogen contamination at an environmental surface of a subsequent location of the facility; based upon the predicted probability of pathogen contamination at the environmental surface of the subsequent location of the facility, transmit pathogen action information related to the subsequent location of the facility to the output device; and display a graphical representation of a map of the facility on the output device and identify the location of the first location within the facility, the location of the subsequent location within the facility, and the predicted pathogen contamination at the environmental surface of the subsequent location by highlighting the location of the first location within the facility, highlighting the location of the subsequent location within the facility, and highlighting the predicted pathogen contamination at the environmental surface of the subsequent location on the graphical representation of the map of the facility.
 13. The pathogen detection and display system of claim 12, wherein the primary pathogen sample information is configured as at least one of a pathogen sample type, a pathogen sample collection time, and a pathogen sample collection location.
 14. The pathogen detection and display system of claim 12, wherein the secondary pathogen sample information is configured as at least one of a pathogen sample type, a pathogen sample collection time, and a pathogen sample collection location.
 15. The pathogen detection and display system of claim 12, wherein the pathogen action information is configured as at least one of: information indicating a time to collect a sample; information indicating a location to collect a sample; information indicating a process by which to collect a sample; information indicating a type of sample to collect; and information indicating an instruction following collection.
 16. The pathogen detection and display system of claim 15, wherein the information indicating an instruction following collection is configured as an instruction related to the pathogen.
 17. The pathogen detection and display system of claim 12, wherein the control system is configured to: define a patient perimeter as the pathogen transmission factor, the patient perimeter associated with a patient location within the facility; and when transmitting pathogen action information associated with the primary pathogen sample information to the output device, the control system is configured to transmit pathogen action information associated with the primary pathogen sample information to the output device based upon the correlation of the primary pathogen sample information, the pathogen transmission factor, and the patient perimeter.
 18. The pathogen detection and display system of claim 12, wherein the control system is configured to define a patient perimeter as the pathogen transmission factor, the patient perimeter associated with a patient location within the facility; and wherein the pathogen action information identifies environmental surfaces relative to the patient perimeter that are excluded from a pathogen sampling procedure.
 19. The pathogen detection and display system of claim 12, wherein when receiving subsequent secondary pathogen sample information related to the pathogen associated with the environmental surface of the first location of the facility, the control system is configured to receive secondary pathogen sample information in a substantially continuous manner; and when updating the pathogen transmission factor based upon the subsequent secondary pathogen sample information, the control system is configured to adjust, by the control system, a database of pathogen transmission factors to adapt collection methods and locations based upon historical results.
 20. The pathogen detection and display system of claim 12, wherein the control system is further configured to repeat an audit process of: following transmission of the pathogen action information, receive secondary pathogen sample information related to the pathogen associated with the environmental surface of the subsequent location of the facility; updating the pathogen transmission factor based upon the secondary pathogen sample information; when the subsequent secondary pathogen sample information identifies one of a negative result at the environmental surface of the subsequent location of the facility, and a positive result at the environmental surface of the subsequent location of the facility execute a discriminant analysis based upon the updated pathogen transmission factor to predict a probability of pathogen contamination at another subsequent second location of the facility; and based upon the predicted probability of pathogen contamination at the subsequent location of the facility transmit pathogen action information related to the another subsequent location of the facility.
 21. The pathogen detection and display system of claim 12, wherein the size of the pathogen colony comprises at least one of an area of the pathogen colony, a volume of the pathogen colony, a mass of the pathogen colony, and a percentage of the environmental surfaces contaminated with pathogen.
 22. The pathogen detection and display system of claim 21, wherein the size of the pathogen colony comprises at least one of an area of the pathogen colony, a volume of the pathogen colony, a mass of the pathogen colony, and a percentage of the environmental surfaces contaminated with pathogen. 